You the people are speaking up about the benefits of medical marijuana. You are being certified for Pennsylvania medical marijuana use in record numbers. You are lining up to share your comments about CBD with federal regulators.
In short, you are expressing your belief in a safe treatment option that promises better health and a vibrant quality of life.
Feds seek comments
On May 31, the U.S. Food and Drug Administration plans a public hearing in Silver Spring, MD, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”
Can’t make it to Maryland that day? The FDA still wants to know your thoughts.
The FDA’s scrutiny includes a look at food and drink infused with cannabidiol, one of the active ingredients of marijuana. Cannabidiol doesn’t cause the “high” associated with marijuana, but a rising body of research and experience shows its promise in treating seizures, anxiety, insomnia, inflammation, and neuropathic pain.
The FDA is seeking answers to three questions, in particular: Is hemp-derived CBD safe to consume in supplements and foods? What standards are needed to ensure quality and consistency? How should labeling and marketing be regulated?
Experts from the medical marijuana community advise that comments should be linked to scientific evidence. While the hundreds of comments submitted initially included many that were purely anecdotal or opinions (“It comes from a plant, please don’t regulate. Thank you,” read the entirety of one comment), others cited research and science backing claims of effectiveness.
The goal of the hearing is to “inform our regulatory oversight of these products,” said Principal Associate Commissioner for Policy Lowell Schiller. The FDA doesn’t intend to produce decisions or new positions, “but this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”
Want to put in your two cents’ worth? The FDA is taking comments through July 2. Visit the Federal Register online, or send written comments, including Docket No. FDA-2019-N-1482, to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
PA medical marijuana certifications on the rise
Under the Pennsylvania Medical Marijuana Program, medical marijuana isn’t available by prescription from a physician. However, a doctor’s approval is needed before anyone can walk into a dispensary and buy medical marijuana.
Here’s how it works: Pennsylvania lists 21 medical conditionsthat qualify patients for medical marijuana use. Conditions include PTSD, epilepsy and intractable seizures, chronic pain, Parkinson’s disease, and opioid use disorder.
Patients who want access to medical marijuana must first register for participation. Then they must schedule an appointment with a physician approved to certify that they have one of the 21 conditions. That certification allows patients to apply for medical marijuana ID cards, proving their eligibility to purchase medical marijuana at a licensed dispensary.
In mid-April, the Wolf Administration announced that Pennsylvania topped the 100,000 mark in patient certifications by physicians. At the same time, the first grower/processor approved in the state’s second round of licensing had started operations. With FarmaceuticalRx, LLC, operating in the Mercer County town of Farrell, Pennsylvania has 13 grower/processors producing medical marijuana according to strict standards of purity and quality.
“Realizing 100,000 patient certifications and seeing the first Phase II grower and processor operationalized is a testament to the hard work of the Department of Health, the many advocates for this program, and our General Assembly who passed this legislation nearly three years ago,” Governor Tom Wolf said. “It’s progress that is making a difference in the lives of many Pennsylvanians.”
Wolf’s office announced more numbers showing the extent of medical marijuana delivering relief into homes and communities:
- 131,000 patients registered.
- 1,500 physicians registered, and 1,099 approved as practitioners.
- 50 dispensary permits and 46 approved locations.
- 780,000 “dispensing events” across all dispensaries, with more than 2.2 million products sold.
Pennsylvania Health Secretary Dr. Rachel Levine called medical marijuana “an important tool for patients and physicians to treat one of the 21 approved serious medical conditions.” Shereminded patients that certifications come with expiration dates, “and they have to visit an approved doctor to renew it.”
“While many certifications are for 12 months, some may be for three, six or nine months, so it is important to talk with your doctor to set up your recertification appointment,” she said.